2009, Percutaneous Coronary Intervention versus CABG for Severe Coronary Artery Disease, NEJM
SYNTAX Trial Summary
SYNTAX trial was a noninferiority, randomized, prospective, multicenter (85 sites in 17 countries), open label, industry sponsored, parallel-group trial to investigate the outcomes (at 12 monthsof follow up) with two different revascularization strategies- PCI (with Taxus Express paclitaxel-eluting stents) vs. CABG, in patients with known LMCAD (with or without additional epicardial CAD)or 3 vessel CAD. The lesions had to be >=50%, previously untreated, and in patients with angina or atypical chest pain or asymptomatic with evidence of myocardial ischemia. Patients were screened between March 2005 and April 2007, and 1800 patients were randomly assigned (1:1) to either of the groups. They were also stratified according to the presence or absence of LM CAD. Coronary angiograms were scored according to the SYNTAX score algorithm. The primary end point of major cardiac or cerebrovascular events (cumulative of death from any cause, stroke, MI, and repeat revascularization) at 12 months were significantly higher in the PCI group than CABG group (17.8% vs. 12.4%; P =0.002). At 12 months, individual components of primary end point- death from any cause and MI were similar in the two groups, but stroke rates were higher in the CABG group whereas repeat revascularizations were higher in the PCI group. The rates of major cardiac or cerebrovascular events were similar in the two groups (PCI & CABG) and higher in the PCI group in the pre-stratified subgroups of LM CAD and 3 vessel CADrespectively. Of importance, the rates of major cardiac or cerebrovascular events were similar in the two groups for the low SYNTAX score (<=22), non-statistically numerically higher in the PCI group for the intermediate SYNTAX score (23-32), and statistically higher in the PCI group for the high SYNTAX score (>=33).
Serruys, P.W. et al. NEJM. March 2009.